CMS Final Rule

Bowing to pressure from the AAFP and other stakeholder groups, CMS recently announced a final rule(www.federalregister.gov) regarding the Medicare Part D prescription program that leaves out a controversial proposal that would have removed two drug classes from a protected list of covered medications.

When the rule was first proposed in January 2014, the plan to drop the two drug classes drew heavy criticism from medical organizations and the media. In fact, CMS received more than 7,500 comments on the proposed rule.

“Based on the comments received, we have concluded that our proposed criteria did not strike the balance among beneficiary access, quality assurance, cost-containment, and patient welfare that we were striving to achieve,” CMS stated in the final rule. “We are not finalizing our proposal to establish new criteria for the categories and classes of clinical concern.”

The agency further noted, however, that although it has not modified the protected drug classes at this time, it might revisit the issue in the future.

The AAFP had objected to the proposed changes to Medicare Part D prescription drug formularies in a February 2014 letter to CMS. The letter noted that primary care physicians make the majority of depression diagnoses and prescribe more than half of all antidepressants for patients.

The Academy said that restricting access to these medications could increase health costs in other areas, such as by provoking longer hospital stays among acute-care patients and more ER visits by Medicaid patients.

Other sections of the rule were maintained as initially proposed, however, including a requirement that physicians who prescribe Medicare Part D drugs enroll in Medicare or have a valid reason for opting out of the program.

The AAFP had opposed this proposal, arguing that physicians’ prescriptive authority is already regulated by the DEA and that such a requirement could deny a patient access to needed medication simply because the physician is not enrolled in Medicare. But CMS stuck to its guns, noting that the requirement is intended to protect against potential fraud by ensuring that only qualified physicians are writing prescriptions.

It's worth noting that although the rule requires physicians who wish to prescribe these drugs to enroll in Medicare by June 2015, it does not require them to participate in Medicare.

Finally, CMS will have new authority under the final rule to revoke a physician’s enrollment in Medicare if the physician has a history of abusive or improper prescription practices or has his/her license suspended or revoked by the DEA or by the licensing body in the state in which the physician is licensed. In its February letter, the AAFP largely supported this proposal, finding it, in general, to be "reasonable."